DiabetesPhase 1NCT02016911
Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Hepatic Impairment
A Phase 1 study testing semaglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 6 sites in 3 countries.
Trial summary
This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability of oral semaglutide (NNC0113-0217) in subjects with mild, moderate and severe degrees of hepatic impairment compared to subjects with normal hepatic… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2, Healthy
- What is being tested?
- semaglutide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 12 Dec 2013to 12 Jan 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject with normal hepatic function or hepatic impairment (mild, moderate or severe)
- Body mass index (BMI) 18.5-40.0 kg/m^2 (both inclusive)
Who cannot join
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods
- History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
- Uncontrolled hypertension (defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg)
- Any donation of blood or plasma in excess of 400 mL within the 3 months preceding screening
- History of significant drug abuse, or a positive drug test at the screening visit (Visit 2)
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Poland3 sites
Novo Nordisk Investigational Site
Bialystok, 15-879
Novo Nordisk Investigational Site
Warsaw, 02-507
Novo Nordisk Investigational Site
Wołomin, 05-200
Czechia2 sites
Novo Nordisk Investigational Site
Prague, 10034
Novo Nordisk Investigational Site
Prague, 17000
About this study
Official title: Investigation of Pharmacokinetics, Safety and Tolerability of Oral Semaglutide (NNC0113-0217) in Subjects With Mild, Moderate and Severe Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function
This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability of oral semaglutide (NNC0113-0217) in subjects with mild, moderate and severe degrees of hepatic impairment compared to subjects with normal hepatic function.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2, Healthy
- Being tested
- semaglutide
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semaglutideDrug
Once daily oral administration of semaglutide formulated with SNAC. Dose escalation, with 5 days on 5 mg followed by 5 days on 10 mg
| Study group | Role | What they receive |
|---|---|---|
| Subjects with hepatic impairment | Experimental | Not described Receives: Drug: semaglutide |
| Subjects with normal hepatic function | Active comparator | Not described Receives: Drug: semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the semaglutide plasma concentration curve
Measured: From time 0 to 24 hours after the 10th dosing
Secondary outcomes (3)
Maximum observed semaglutide plasma concentration
Measured: 0 to 24 hours after the 10th dosing
Area under the SNAC (Sodium N-[8-(2-hydroxybenzoyl) amino] caprylate /salcaprozate sodium) plasma concentration time curve
Measured: From time 0 to 24 hours after the 10th dosing
Maximum observed SNAC plasma concentration
Measured: 0 to 24 hours after the 10th dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study start12 Dec 2013
- Primary completion12 Jan 2015
- Study completion12 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016911
- Sponsor's protocol ID
- NN9924-4082
- Other IDs
- 2013-000550-21, U1111-1139-1272
- Status last verified
- May 2018
- First submitted
- 12 Dec 2013
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Baekdal TA, Thomsen M, Kupcova V, Hansen CW, Anderson TW. Pharmacokinetics, Safety, and Tolerability of Oral Semaglutide in Subjects With Hepatic Impairment. J Clin Pharmacol. 2018 Oct;58(10):1314-1323. doi: 10.1002/jcph.1131. Epub 2018 Apr 25.
PubMed 29693715Overgaard RV, Navarria A, Ingwersen SH, Baekdal TA, Kildemoes RJ. Clinical Pharmacokinetics of Oral Semaglutide: Analyses of Data from Clinical Pharmacology Trials. Clin Pharmacokinet. 2021 Oct;60(10):1335-1348. doi: 10.1007/s40262-021-01025-x. Epub 2021 May 10.
PubMed 33969456
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Pharmacokinetics, Safety and Tolerability of Oral Semaglutide (NNC0113-0217) in Subjects With Mild, Moderate and Severe Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT02016911
- Acronym / sponsor ID
- NN9924-4082
- Conditions
- Diabetes, Diabetes Mellitus, Type 2, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2013 (actual)
- Primary completion
- 12 Jan 2015 (actual)
- Study completion
- 12 Jan 2015 (actual)
- First posted
- 20 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability of oral semaglutide (NNC0113-0217) in subjects with mild, moderate and severe degrees of hepatic impairment compared to subjects with normal hepatic function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with hepatic impairment | Experimental | Drug: semaglutide |
| Subjects with normal hepatic function | Active comparator | Drug: semaglutide |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject with normal hepatic function or hepatic impairment (mild, moderate or severe)
- Body mass index (BMI) 18.5-40.0 kg/m^2 (both inclusive)
Key exclusion criteria (5 listed)
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods
- History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
- Uncontrolled hypertension (defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg)
- Any donation of blood or plasma in excess of 400 mL within the 3 months preceding screening
- History of significant drug abuse, or a positive drug test at the screening visit (Visit 2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| semaglutideOnce daily oral administration of semaglutide formulated with SNAC. Dose escalation, with 5 days on 5 mg followed by 5 days on 10 mg | Drug | Subjects with hepatic impairment, Subjects with normal hepatic function |
Primary outcome
Area under the semaglutide plasma concentration curve
Time frame: From time 0 to 24 hours after the 10th dosing
3 secondary outcomes
Maximum observed semaglutide plasma concentration
Time frame: 0 to 24 hours after the 10th dosing
Area under the SNAC (Sodium N-[8-(2-hydroxybenzoyl) amino] caprylate /salcaprozate sodium) plasma concentration time curve
Time frame: From time 0 to 24 hours after the 10th dosing
Maximum observed SNAC plasma concentration
Time frame: 0 to 24 hours after the 10th dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
- Results publication: PubMed 29693715Baekdal TA, Thomsen M, Kupcova V, Hansen CW, Anderson TW. Pharmacokinetics, Safety, and Tolerability of Oral Semaglutide in Subjects With Hepatic Impairment. J Clin Pharmacol. 2018 Oct;58(10):1314-1323. doi: 10.1002/jcph.1131. Epub 2018 Apr 25.
- Derived from this study: PubMed 33969456Overgaard RV, Navarria A, Ingwersen SH, Baekdal TA, Kildemoes RJ. Clinical Pharmacokinetics of Oral Semaglutide: Analyses of Data from Clinical Pharmacology Trials. Clin Pharmacokinet. 2021 Oct;60(10):1335-1348. doi: 10.1007/s40262-021-01025-x. Epub 2021 May 10.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing semaglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Poland, Czechia, Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the semaglutide plasma concentration curve (time frame: From time 0 to 24 hours after the 10th dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02016911, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2018.